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Written by Katia Merten-Lentz and Oliver Hartmann

At the beginning of this year, the Directorate General for Health and Food Safety of the  European Commission (DG SANTE) published its findings in relation to the Fitness Check of the General Food Law Regulation (EC) No 178/2000  (GFL Regulation), which had been concluded by the end of 2017. Here, Katia Merten-Lentz and Oliver Hartmann at international law firm, Keller and Heckman, look at this check-up found shortcomings in transparency.

As the foundation of the EU’s food law, the GFL Regulation covers the entire food chain, notably all stages of production, processing and distribution of food and feed, including import – also known as the ‘farm to fork’ approach.

It contains general principles of food law, including the principle of risk analysis, making a distinction between risk assessment, risk management and risk communication and the precautionary principle, and general requirements of food law, such as food safety and traceability. Of course, the GFL Regulation also provides for the establishment of the European Food Safety Authority (EFSA).

The Fitness Check of the Regulation was conducted to evaluate whether the established general principles and requirements are appropriate for the purpose by identifying excessive regulatory burdens, overlaps, gaps, inconsistencies and/or obsolete measures.

In general, the REFIT evaluation found that the GFL Regulation remains relevant and has succeeded in achieving a high level of protection of human health and consumers’ interests in relation to food, while contributing to the effective functioning of the internal market.

However, certain shortcomings were identified.

One of the main findings regarding these shortcomings was the increased negative perception by the civil society of EFSA and its risk assessment process of regulated substances – such as, for example, enzymes, additives, pesticides or flavourings – based on studies financed by the industry. In particular, the findings emphasized in this regard that:

“[…]EFSA is bound by strict confidentiality rules that are laid down in the GFL Regulation and in the multiple authorisation procedures in EU secondary food legislation. The application of the confidentiality rules creates the perception of a certain lack of transparency. This perception is further reinforced by the civil society’s concerns over EFSA’s independence from industrial interests, as EFSA bases its risk assessment on authorisation dossiers on studies conducted by the industry. These criticisms in turn can have a negative impact on the acceptability of EFSA’s scientific work by the general public. There is therefore a need to address perceived issues with respect to the transparency as well as the reliability and independence of studies underpinning EFSA’s assessments […].”

Taking these findings into account, the Commission launched at the end of December 2017 the roadmap initiative “Transparency and sustainability of the EU risk assessment model in the food chain” .

A main objective of the initiative is to clarify and improve the transparency of the scientific studies supporting the risk assessment of substances subject to pre-market approval carried out by EFSA.

“One of the main findings was the increased negative perception by the civil society of EFSA and its risk assessment process of regulated substances based on studies financed by the industry”

By way of background, the GFL Regulation subjects EFSA to comprehensive transparency obligations, since its adoption in 2002, per Article 38.

As part of these obligations, EFSA is required to publish, inter alia, agendas, minutes and opinions of the Scientific Committee and Scientific Panels, the information on which its opinions are based, the results of its scientific studies as well as the annual declarations of interest of certain individuals from its staff.

Hence, “a high level of transparency” as formulated in Article 38 of the GFL Regulation is already being implemented in EFSA’s activities.

EFSA’s transparency obligation must be read in conjunction with Article 39 that lays down rules on confidentiality constituting a derogation from Article 38.  In accordance with Article 39, EFSA may not disclose information, that was received and for which confidential treatment has been requested, to third parties.

This general provision of the GFL Regulation is complemented by confidentiality rules set out in sectoral EU food legislation such as Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. Of further relevance, Regulation (EC) No 1049/2001 regulates the right of access by the public to documents of the EU institutions and agencies, like EFSA.

On 11 April, the roadmap initiative resulted in the publication of the Commission’s legislative proposal on the transparency and sustainability of the EU risk assessment model in the food chain , amending principally the GFL Regulation and introducing, amongst other things, significant changes to rules on transparency and confidentiality under Articles 38 and 39. Besides the changes to the GFL Regulation, the Commission proposal amends, at the same time, relevant provisions of sectoral EU food legislation pertaining to GMOs, feed additives, smoke flavourings, food contact materials, food additives, food enzymes, flavourings, plant protection products and novel foods.

In particular, the proposal amends Article 38 by extending EFSA’s transparency obligations specifically to scientific data, studies and other information supporting applications for authorization of substances regulated under EU food law, including supplementary information supplied by applicants.

On this basis, EFSA is required to disclose scientific studies generated by the industry for the risk assessment of regulated substances. However, it is important that the obligation by EFSA to disclose such information does not affect any existing intellectual property rights and data exclusivity provisions established in sectoral food legislation. In addition, certain information may be protected as confidential in line with Article 39 as revised by the proposal.

Of relevance, the amended Article 39 restricts confidential treatment in principle to the following four types of information:

  • the method and other technical and industrial specifications relating to the method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion;
  • commercial links between a producer or importer and the applicant or the authorisation holder, if applicable;
  • commercial information revealing sourcing, market shares or business strategy of the applicant;
  • quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion.

When requesting confidential treatment of such information positively identified in the revised provision of Article 39, the respective applicant must still provide verifiable justification that disclosure significantly harms its (commercial) interests.

This approach adopted by the Commission could have repercussions for the promotion of innovation and stimulating research and development within the agri-food sector.

Interestingly, the amended Article 39 envisages that information may still be made publicly available, even if it is considered confidential, under the condition that urgent action is essential to protect public health, animal health or the environment, or that such information is part of the conclusions of EFSA opinions and relates to foreseeable health effects. In other terms, an overriding provision has been incorporated allowing for EFSA to disclose confidential information under certain circumstances.

Another novelty introduced by the proposal is that if an applicant requests confidentiality for certain parts of a scientific study generated, the applicant must submit a confidential and non-confidential version of the study concerned to EFSA. The Authority then publishes the non-confidential version of submitted study, while it will assess and decide on the confidentiality request for the identified information.

The proposal determines that the publication of the non-confidential version of the scientific study and the assessment of the confidentiality request must be conducted without delay by EFSA.

If EFSA takes the view that the confidentiality request cannot be supported, EFSA is obliged to inform the applicant of its intention to disclose the information and the reasons prior to taking the formal decision.

Following the notification of EFSA’s position, the applicant has the opportunity to state its views or withdraw the application. The next stage of this procedure, EFSA must adopt a reasoned decision on the confidentiality request taking into account the views of the applicant, where submitted within ten weeks from the date of receipt of the confidentiality request.

Consequently, any information for which the confidentiality request is considered not justified, would be made public, unless the corresponding application was withdrawn by the applicant before the decision on the confidentiality request by EFSA.

Openness of scientific studies

The tabled proposal demonstrates the Commission’s willingness to ensure that most of the content of the scientific studies provided by the industry for the risk assessment process are made public.

While intellectual property rights and data exclusivity provisions established in sectoral food legislation are still protected, the grounds for confidential treatment of information are narrowly defined so that the proposal restricts the possibility significant for the industry to keep information and data included in scientific studies confidential.

This approach adopted by the Commission could have repercussions for the promotion of innovation and stimulating research and development within the agri-food sector. More specifically, the extension of transparency and the restriction of confidentiality facilitates the publication of data submitted for the risk assessment of a regulated substance that could allow competitors of the given applicant to potentially use, one way or another, the generated data for the substance concerned without having to face the same costs and efforts.

In terms of next steps, the Commission proposal is submitted to the Council and the Parliament for review taking into account that the two EU institutions as co-legislators may table amendments to the proposal. It, therefore, remains to be seen to what extent the initial provisions of the proposal are kept.

 

This article was first published by EU Food Law on April 19, 2018.

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Katia Merten-Lentz provided her expertise on plant-based meat and cultured-meat for the recently published research paper Meat Analogues: Considerations for the EU. The paper was published by Chatham House, The Royal Institute of International Affairs, which is a world-leading policy institute based in London whose mission is to help governments and societies build a sustainably secure, prosperous and just world.

Keller and Heckman’s Food and Drug practice continues to monitor the developing plant-based meat and cultured-meat industry. Late last year Katia Merten-Lentz published “In vitro meat: regulatory issues in the US and the EU” for EU Food Law. In addition, Keller and Heckman’s The Daily Intake Blog has published multiple articles on the topic.

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Keller and Heckman food law attorney Katia Merten-Lentz was interviewed for the Le Monde article (in French) “Des insectes dans notre assiette, en toute légalité?” which reported on the recent European Commission decision on insect-based food for human consumption confirming that prior authorization is required. Keller and Heckman’s Food and Drug Practice has been monitoring this topic, for a brief history of the legislation (in English) click here and for a succinct summary of the legislation (in English) click here.

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Cet article a été publié sur Les Marchés, le Média de l’alimentaire.

 

Le 16 novembre, le ministère de l’Agriculture des États-Unis et l’administration des denrées alimentaires américaine ont annoncé qu’ils étaient parvenus à un accord sur un cadre réglementaire commun pour la viande cultivée en laboratoire.

Au cours des dernières années, le prix de la viande cultivée en laboratoire a considérablement chuté. L’arrivée prochaine de ces viandes sur le marché pose la question de leur statut réglementaire et de leur étiquetage mais aussi de leur sécurité. La déclaration, publiée par le ministère de l’Agriculture (USDA) et l’administration des denrées alimentaires et des médicaments (FDA) des États-Unis, mi-novembre, constitue une étape importante dans la mise en place d’un tel cadre réglementaire pour la viande in vitro. Les agences ont ainsi décidé de superviser conjointement la production de viande in vitro aux États-Unis : la FDA contrôlera les premières étapes de la culture cellulaire et l’USDA surveillera la production et l’étiquetage de viande in vitro. Reste à définir la réglementation qui s’appliquera à ce produit.

 

Évaluation de la sécurité de la viande in vitro

Aux États-Unis, un premier obstacle juridique important concerne le statut de la viande in vitro, qui ne correspond pas vraiment à la définition de « meat product » au sens de la loi fédérale sur l’inspection des viandes, dans la mesure où cette définition implique que le produit soit dérivé d’une carcasse.

En outre, il est possible que la structure à laquelle les cellules se fixent pour se développer et les facteurs de croissance cellulaire utilisés pour la « culture » de la viande in vitro soient considérés comme des additifs. Si tel est le cas, ces substances devront être autorisées, à moins de respecter les deux critères permettant d’être qualifiées comme “gras”, à savoir : qu’il existe une certitude raisonnable que la substance ne soit pas dangereuse ; et que son utilisation dans les aliments soit reconnue comme sûre par des experts qualifiés, sur la base d’informations scientifiques accessibles au public.

Un nouvel aliment dans l’UE

Dans l’Union européenne (UE), le statut réglementaire de la viande in vitro a récemment été défini : la viande in vitro devra être autorisée comme un nouvel aliment. En effet, elle se rattache à une catégorie du règlement sur les nouveaux aliments faisant explicitement référence aux aliments produits à partir de cultures cellulaires ou de cultures de tissus dérivés d’animaux. Les entreprises voulant se lancer dans la commercialisation de viande de laboratoire devront donc présenter une demande incluant toutes les données scientifiques pertinentes, qui sera évaluée par l’Efsa, puis la viande in vitro devra être officiellement autorisée par la Commission européenne. La Commission a récemment informé qu’aucune demande d’autorisation n’avait été reçue à ce jour.

Problèmes d’étiquetage et de dénomination

Plusieurs questions se posent concernant le futur étiquetage de la viande in vitro dans l’UE, notamment quant à la dénomination du produit, qui doit figurer obligatoirement sur le produit en application du règlement Inco. La viande in vitro n’étant pas encore sur le marché, il n’existe pas de nom légal, mais de nombreux noms « commerciaux » coexistent déjà (viande in vitro, viande de culture, viande propre, viande de laboratoire, etc.). Dans tous les cas, il sera nécessaire d’indiquer clairement le mode de production « en laboratoire » dans le nom, afin d’assurer une bonne information du consommateur.

De plus, la viande in vitro ne correspond pas à la définition du règlement Inco de « viande », qui implique des muscles squelettiques avec des tissus inclus naturellement ou adhérents, dans la mesure où la viande créée en laboratoire correspond à un amas de cellules musculaires. En principe, le terme « viande » ne pourra donc pas être utilisé dans l’état actuel de la législation de l’UE. Les mêmes problèmes de dénomination se posent pour les États-Unis, dans la mesure où la viande in vitro ne correspond pas exactement à la définition de « meat product ».

Les prochaines déclarations des agences publiques américaines sont très attendues, car elles se prononceront, les premières, sur le futur cadre réglementaire de la viande in vitro.

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Where does laboratory produced meat fit in the regulatory frameworks of the US and the European Union?

Meat produced in a laboratory is close to coming to market, raising questions about the regulatory hurdles the US and EU may put in place

Published 11 Dec 2018 at EU Food Law

ANALYSIS

On 16th November 2018, the US Department of Agriculture and the US Food and Drug Administration announced that they had reached an agreement on a joint regulatory framework on laboratory made, cultured meat, also called in vitro meat. The Agencies have not yet revealed which framework will apply to this new way of making meat, but their respective roles have been clarified, as Katia Merten-Lentz of international law firm, Keller & Heckman, reports.

Cultured meat, or in vitro meat, is a form of cellular agriculture allowing the growth of meat from animal cells. Over the last few years, the price of producing this meat has dropped drastically, raising the possibility of these meats hitting the market.

However, these developments have also raised questions about their regulatory status, safety and labelling issues.

The statement released by the USDA and the FDA in November is another step towards the setting up of a regulatory framework regarding in vitro meat. The agencies have decided to oversee jointly the production of in vitro meat , according to their regular competencies: the FDA will oversee the first stages regarding cell-culture technology, and USDA the production and labelling of in vitro-meat. The joint statement of USDA and FDA does not explain which regulatory status will be applied to lab meat. But this status – as well as labelling issues – will have to be settled before the meat is placed on the market.

 

Regulatory status and safety assessment of meat in vitro

The US and EU regulatory framework regarding meat in vitro will differ.Regarding the US, several hypotheses can be explored. The first important hurdle is that it is arguably difficult to consider that in vitro meat fits in the definition of “meat product” as defined in the Federal Meat Inspection Act (FMIA), since FMIA assumes a meat food product is derived from a carcass.

If FMIA is inapplicable to culture meat, the rules regarding conventional foods would probably apply, and the FDA’s Biotechnology Policy could provide some help  in analysing the status of cultured meat.

It is also possible that in vitro meat could be considered to be a food additive.

The current method for growing in vitro meat consists of using a cell culture medium or scaffold, which is a structure where the cells attach to in order to allow growth, and cellular growth factors.

As explained by the Food and Drug Law Institute , the FDA may consider that these substances are food additives, since they are intentionally added to a food.

If it is the case, they will have to be authorised, unless they meet the two so called GRAS criteria (generally recognized as safe) i.e.: there is a reasonable certainty of no harm; and the intended use of the substance in food must be recognised as safe by qualified experts based on publicly available scientific information (general recognition standard).

Moreover, the safety of the primary cells used would also have to be asserted, since they are genetically modified cell lines. This may pose a hurdle, as, according to the US Consumers Union, “these lines exhibit the characteristics of a cancerous cell”.

In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.

Indeed, in vitro meat falls under a relevant category in the Novel Foods Regulation that explicitly refers to food produced from cell culture or tissue culture derived from animals.

In its answer to a parliamentary question on this topic in October, the European Commission confirmed that in vitro meat may fall in this category and must then be considered as a novel food.

In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.

For being authorised as a novel food, the producers of in vitro meat will have to file an application which must include all relevant data.If the product is deemed safe after a scientific assessment by the European Food Safety Authority (EFSA), the Commission can enact a Regulation to authorise in vitro meat.  The Commission recently confirmed that no application for the authorisation of in vitro meat has been received so far.

Therefore, in vitro meat cannot yet be placed on the market, and any such meat would be seized by the authorities.

This is what happened in December 2017, when tasting experiments of cultured meat made by the company JUST were organized in the Netherlands, and the Dutch Safety Authority sealed the products to prevent them from being consumed.

Issues regarding labelling

The Novel Foods Regulation states that when novel foods are added to the Union list of authorized novel food, there can be requirements regarding labelling, in order to fully inform the consumer, for instance by describing the food or its composition. It is more than likely that specifications will be added for in vitro meat.

In any case the EU Regulation on Food Information to Consumers (also known as ‘the FIC Regulation’) will apply to in vitro meat once it is authorised, but its application may prove challenging.

For instance, there is an obligation to indicate on the label the denomination of a food, but there are unsolved issues regarding the denomination of in vitro meat.

Since this food is not on the market yet, there is no legal name and no customary name either. Many names already coexist (in vitro meat, cultured meat, clean meat, lab meat, etc.), and the choice of the name is quite touchy.

Since the FIC Regulation’s main objective is to ensure that fair, clear and precise information is provided to the consumers – for instance about the manufacturing or production method – it seems very likely that operators will have to ensure that the product name makes clear that the meat has been grown in a lab.

Moreover, in vitro meat does not comply with the current European definition of “meat”. According to the FIC Regulation, the definition of meat – for labelling purpose – is: ‘skeletal muscles of mammalian and bird species recognised as fit for human consumption with naturally included or adherent tissue (…)’.  In vitro meat neither consists of “skeletal muscles” (‘muscles under the voluntary control of the somatic nervous system’) nor of ‘naturally’ included or adherent tissues, so it would mean that the term ‘meat’ could not be used in the current state of the EU legislation.

For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.

The exact same issue applies for the US as in vitro meat does not comply exactly with the definition of “meat food product” under FMIA. In the EU, there are also specific issues regarding the labelling of meat that will be difficult to apply to in vitro meat.

Several regulations make the indication of the country of origin or place of provenance of meat mandatory.  However, for in vitro meat, since there is no animal being born, reared or slaughtered, it will be virtually impossible to apply this disposition.

In the US, the public is given the opportunity to comment on the regulatory issues regarding lab meat until 26 December 2018. The expected statements that will follow from the public agencies will hopefully reveal for operators the first outlines for a regulatory framework for in vitro meat.

For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.

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Published 28 November 2018 at EG Policy and powered by EU Food Law.

 

In April 2018, the European Commission officially proposed a targeted revision of the General Food Law Regulation (EC 178/2002) to improve the transparency of scientific studies in the food safety area, writes Katia Merten-Lentz of international food law firm Keller & Heckman.

This proposal follows a European Citizens’ Initiative submitted in October 2017 focusing on pesticides and food safety.

However, the main principles of food safety in the EU, i.e. responsibility of the operator and traceability, will not be part of this revision.

The Commission recently explained in its answer to a parliamentary question that the current framework had resulted, globally, in positive outcomes and did not have to be amended for now.

 

Keeping the preventative approach

European food safety regulation is primarily based on a preventive approach, in which food business operators (FBOs) hold the primary legal responsibility for ensuring compliance with food law.

The legal framework results from two main instruments combined:

  • the General Food Law Regulation (GFL), which lays down the general principle that all operators in the supply chain may only place safe foods on the market; and
  • the EU Regulation (No 852/2004) on the hygiene of foodstuffs.

The EU Regulation on hygiene states that FBOs must implement a food safety management system, which prevents and reduces food-borne hazards, and which is based on the hazard analysis and critical control point (HACCP) principles.

These flexible principles are developed to enable operators to identify points during the production where potential hazards may occur (related to harmful microorganisms, chemical hazards, packaging or equipment quality, etc), analyse the probability of those hazards happening, and set up controls and corrective actions to tackle them, such as sampling the food to check microbiological criteria for instance.

The Regulation on hygiene also provides a set of rules on good hygiene practice, covering aspects like cleaning and disinfection, pest control, waste management, hygiene of the staff and transport.

Operators must also ensure that products comply with specific EU provisions on safety, such as the regulations setting up maximum levels for certain contaminants and residue levels of pesticides in food, beyond which a food may not be placed on the market.

If, despite the preventive measures, an unsafe product is placed on the market, the GFL Regulation provides for additional dispositions to protect the safety of consumers.

The GFL imposes general obligations on food business operators in terms of traceability, notification of food safety incidents and withdrawal and recall of unsafe food.

The obligation of ‘traceability’ means that the operator must be able to identify both their suppliers and customers through all stages of production, processing and distribution. Traceability is essential to facilitate withdrawal and recall of food.

Indeed, if an operator believes that a food that it has imported, manufactured or distributed is not in compliance with food safety requirements, he or she must withdraw it immediately, by removing it from the supply chain. If this product might have been already bought by consumers, it has to be recalled in addition. The FBO also has to notify the national authorities of the withdrawal as soon as possible.

When a serious health hazard is detected, the national authorities inform the European Commission and the other Member States via a platform called the Rapid Alert System for Food and Feed.  If deemed necessary, the Commission can adopt emergency measures – such as suspending the placing on the market of products – to mitigate the risks.

 

Reform on transparency of the risk assessments for food-related authorisations

After completing, in January 2018, the REFIT on the GFL Regulation, the Commission concluded that the core principles regarding risk analysis, primary responsibilities of FBO and traceability, have been successful in protecting public health.

However, the Commission noted a lack of trust from the citizens regarding transparency of risk analysis, particularly with regard to the authorisation dossiers.

While on the one hand the operators are responsible for the safety of the products they put on the market, on the other hand, the European Food Safety Authority (EFSA) plays a major part by assessing the dossiers submitted by operators seeking authorisation for novel foods, additives, plant protection products and food improvement agents.

The GFL Regulation lays down that EFSA’s assessment is primarily based on industry studies – therefore generated by the applicant. Moreover, EFSA is bound by strict confidentiality rules with regards to these studies. These elements have a negative impact on consumers’ trust. To tackle this issue, the Commission has made several proposals to ensure more transparency during the risk assessment process.

The reform proposes free access for citizens to all safety related information submitted by the industry, and the creation of an European Register of studies.

The proposal also includes consultation of stakeholders and public on studies submitted by the industry, as well as an increase in the EU member states’ involvement in EFSA. Finally, the Commission also wants to strengthen risk communication to citizens by promoting public awareness and better explaining scientific opinions.

The proposal is currently being examined by the European Parliament in first reading, and the main sticking point in the discussions relates to the level of confidentiality that must be granted to industry studies.

The first trilogues are expected late December and early January, which means that the reform will probably be adopted during the course of 2019, but certainly not under the current Parliament.

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Cet article a été publié sur Agra Alimentation, le média des enjeux de stratégiques et financiers de l’agroalimentaire.

 

Le 27 mai 2018, les députés de l’Assemblée nationale ont voté l’interdiction – temporaire – de toute importation et toute vente de denrées alimentaires contenant du dioxyde de titane, au motif que ses effets négatifs sur la santé humaine justifieraient le recours au principe de précaution. Le dioxyde de titane (E 171) est un additif utilisé dans l’industrie agroalimentaire et cosmétique pour blanchir et intensifier la brillance des confiseries, des plats préparés ou encore des dentifrices. Il s’agit d’une substance « partiellement nanométrique », c’est à dire constituée de particules de dioxyde de titane à l’état dispersé, agrégé ou aggloméré dont la taille varie de quelques dizaines à plusieurs centaines de nanomètres.

Il convient de rappeler qu’en application du règlement (CE) n°1333/2008, les additifs sont des substances qui sont ajoutées aux aliments dans un but technologique.Leur emploi est réglementé et leur présence doit obligatoirement être mentionnée sur les étiquettes des produits concernés. L’Agence européenne de sécurité alimentaire (EFSA) surveille et réévalue régulièrement ces substances.

Néanmoins, dans l’hypothèse où une évaluation des informations disponibles révélerait de possibles effets nocifs sur la santé, mais sans certitude scientifique, des mesures provisoires de gestion du risque peuvent être adoptées dans l’attente d’autres informations scientifiques en vue d’une évaluation plus complète. Il s’agit là du principe de précaution.

 

L’évaluation des risques du TiO2 et les données disponibles

L’autorisation du E 171 sur le territoire européen, depuis 1969, a été confortée par un avis scientifique de l’Autorité européenne de sécurité alimentaire (EFSA) du 28 juin 2016: les données disponibles ne mettaient pas en évidence de problèmes de santé pour les consommateurs. L’agence européenne a donc donné son feu vert à la poursuite de l’utilisation de l’additif, tout en recommandant de nouvelles études sur les effets de la substance sur le système reproducteur.

À ce titre, la Commission européenne a publié un appel à des données scientifiques et techniques sur le dioxyde de titane en tant qu’additif alimentaire en 2017. L’EFSA devrait décider, au cours de l’été 2018, si une nouvelle évaluation de l’additif est nécessaire à la lumière de ces nouvelles données, notamment de quatre études ayant été soumises par la France.

Parallèlement, une étude de l’Institut national de la recherche agronomique (INRA), publiée le 20 janvier 2017, concluait que l’exposition chronique au E 171 favorisait la croissance de lésions précancéreuses chez le rat. L’Agence nationale française de santé (ANSES) a alors été saisie en janvier dernier par les ministères de l’économie, de la santé et de l’agriculture. Elle doit réaliser une étude critique de cette publication et déterminer si le produit « présente un éventuel danger pour les consommateurs ». Les conclusions de l’agence françaises sont attendues pour la fin de l’année.

 

Le principe de précaution et la gestion des risques à l’échelle nationale

Mais c’est au regard de ces seules études et en invoquant le principe de précaution, que les députés ont voté, le 27 mai 2018, la suspension de la mise sur le marché de l’additif E 171, ainsi que des denrées alimentaires en contenant.

En effet, depuis 2016, le Code français de la consommation prévoit qu’en cas de danger grave ou immédiat, le ministre chargé de la consommation et le, ou les, ministre(s) intéressé(s) peuvent suspendre la fabrication, l’importation, l’exportation, la mise sur le marché à titre gratuit ou onéreux d’un produit.

Néanmoins, cette suspension ne peut être ordonnée que pour une durée maximum d’un an et les produits peuvent être remis sur le marché s’ils sont reconnus conformes à la réglementation en vigueur. Le ministre chargé de la consommation doit également entendre sans délai les professionnels concernés et les associations nationales agréées de défense des consommateurs.

 

L’articulation des mesures françaises et européennes

Comme le mentionne l’amendement, ces mesures relèvent aussi des mesures conservatoires qui peuvent être adoptées au titre de la législation alimentaire européenne, en cas d’urgence. Dans ce cas, le risque doit être sérieux et évident, et la suspension doit être proportionnée à ce risque, au regard « des possibilités techniques et économiques et des autres facteurs jugés légitimes en fonction des circonstances en question ». En effet, la mesure d’interdiction ne doit pas imposer plus de restriction au commerce qu’il n’est nécessaire.

De plus, avant d’adopter son arrêté, le gouvernement français devra informer la Commission européenne de la nécessité de prendre des mesures d’urgence à l’échelle européenne. Ce n’est que si la Commission n’agit pas que la France pourra suspendre l’utilisation de l’additif. Or, la Commission semble s’être déjà saisie de la question en chargeant l’EFSA d’évaluer la pertinence des nouvelles données disponibles.

Enfin, la décision de suspension française, qui sera définitivement discutée au Sénat à partir du 26 juin prochain, ne pourra être maintenue que jusqu’à l’adoption de mesures européennes. En pratique, cela signifie que toute décision de gestion des risques qui serait adoptée par la Commission européenne primera sur les mesures françaises, qu’elle décide, ou non, d’interdire l’utilisation du dioxyde de titane des denrées alimentaires.

On ne peut donc que s’étonner de cette initiative française quelque peu prématurée qui rappelle le précédent concernant le BPA…

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Cet article a été publié sur Les Marchés, le Média de l’alimentaire.

 

Le récent développement du commerce alimentaire en ligne suscite à la fois enthousiasme et inquiétudes quant aux conséquences juridiques d’une vente qui se caractérise par l’absence physique à la fois du vendeur et du consommateur. L’Europe se penche sur la question.

En février 2018, la Commission européenne a publié un rapport sur le premier programme de coordination des contrôles du commerce alimentaire en ligne. Les autorités nationales ont été invitées à examiner près de 11 000 sites Internet proposant certaines denrées dans leur pays. L’enquête rapporte 428 offres de nouveaux aliments non autorisés, 351 compléments alimentaires avec des allégations non conformes et 779 offres manifestement non conformes à la législation européenne.

Il convient de rappeler que la législation alimentaire européenne harmonise les règles applicables à la sécurité, à l’hygiène, mais également à l’étiquetage des denrées alimentaires destinées à la consommation. Cependant, l’émergence de nouveaux modes de commercialisation soulève des questions pratiques quant au respect de ces dispositions et au maintien d’une concurrence loyale entre les opérateurs du marché agroalimentaire.

 

Respect des règlements Inco et «novel food»

Au-delà du marketing, des exigences sont applicables au contenu des denrées. La vente alimentaire en ligne est définie en droit européen comme une « technique de communication à distance », c’est-à-dire tout moyen qui, sans présence physique et simultanée du fournisseur et du consommateur, peut être utilisé pour la conclusion du contrat entre eux. Ainsi, l’emballage de la denrée et sa présentation sur le site Internet du vendeur restent soumis aux dispositions du règlement Inco.

Les informations obligatoires doivent donc être fournies avant la conclusion de l’achat et figurer sur le support de la vente à distance, c’est-à-dire sur le site Internet. Elles doivent aussi être transmises au moment de la livraison. La vente en ligne doit, en outre, respecter les règles spécifiques d’étiquetage en ce qui concerne les allégations nutritionnelles et de santé. Seules les allégations autorisées au niveau européen et listées comme telles par la Commission européenne peuvent être mentionnées en ligne, comme sur l’emballage des aliments.

Enfin et aussi logiquement, les « nouveaux aliments » qu’ils soient vendus en ligne ou via des circuits traditionnels de distribution, doivent respecter les règles spécifiques du régime « novel food ». Pour rappel, la mise sur le marché d’aliments nouveaux est soumise à une procédure d’autorisation préalable harmonisée à l’échelle européenne et, par conséquent, seules les substances autorisées peuvent être légalement commercialisées.

Adaptation des contrôles officiels

Le respect des règles de sécurité et d’hygiène et les contraintes logistiques constituent le premier frein au développement du commerce alimentaire en ligne. Le législateur européen a explicitement soumis les produits achetés en ligne au nouveau règlement sur les contrôles officiels, qui s’appliquera à compter du 14 décembre 2019. Ainsi, les autorités nationales pourront commander des produits en ligne sans s’identifier et utiliser les produits achetés en tant qu’échantillons officiels.

La non-conformité des produits vendus en ligne pourra entraîner des sanctions qui seront désormais calculées en fonction des gains économiques réalisés ou d’un pourcentage du chiffre d’affaires et qui s’appliqueront indépendamment du lieu d’établissement de l’exploitant.Les contrôles s’étendront donc aux produits en provenance de pays tiers.

Eu égard au nombre d’infractions constatées, le rappel que l’usage du commerce en ligne n’exonère nullement les opérateurs du respect de la législation alimentaire semblait nécessaire. Il apparaît manifeste que les autorités nationales vont être de plus en plus fermes à l’égard des produits mis en vente en ligne et rétablir ainsi une plus saine concurrence sur le marché.